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Job Description
Quality Control Engineer SHL Medical
US MFG LLC
North Charleston, SC Job Details 1 day ago Benefits Career development plan Qualifications Laboratory testing protocol documentation Test systems Manufacturing automation (as product category for technical sales engineers) Laboratory equipment performance testing and validation Quality control product testing Procedural guides Test equipment calibration Engineering Laboratory instrument validation Technical writing within manufacturing Employee relationship building GMP Training material drafting Mid-level Manufacturing facility Bachelor's degree in engineering Production validation processes Medical device manufacturing facility experience Task prioritization Pharmaceutical company experience Decision making Laboratory compliance Laboratory quality control Compliance documentation Laboratory preventive maintenance Organizational skills Regulatory/legal compliance standards in production Biomedical regulatory compliance Technical skills instruction Training & development
Full Job Description QC Engineer Location:
Charleston, South Carolina, US SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues. Job Overview This role is embedded in the Manufacturing Engineering group within our Global Operations Engineering team at our new state-of-the-art device manufacturing facility in North Charleston, South Carolina. Together, with the rest of the team, you will drive and support manufacturing automation, with a particular focus on our automated assembly equipment used for final production. Main Responsibilities Develop documentation (work instruction, training material, etc.) for the QC Lab Train QC Inspectors to new test methods / equipment Liaison and receive test method / system updates from Metrology, Testing, and transfer team Review planned equipment for QC lab, ensure meets local SHL expectations, and will work in the QC Lab Attend Planning meetings for New Products to understand New Measuring Methods and plans for QC Testing Coordinate local support (calibration / preventive maintenance) for new QC Lab equipment Point of Contact for QC Lab for any upcoming changes or needs Identify problem statements and build relationship with external SHL support teams for issues related to internal systems (SAP, EiQMI, and MES) Manage all QC equipment and tool/fixtures to ensure QC Lab testing for production and validation actvties Performs other related duties as assigned. Skills and Qualification Bachelor's degree in Engineering or Life Science discipline 2+ years of experience in the medical device, pharmaceutical or biotechnology industry Clear / logical thinking with strong organization and communication skills. Ability to prioritize and to thrive in a cross-functional, inter-company and international environment. Team player and self-starter, able to perform with low supervision. A solution-oriented growth mindset coupled with decision-making skills. Experience writing work instructions, training material, and validation documentation.
Preferred:
(nice to have) Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and
ISO 13485
is preferred. SAP (Enterprise Resource Planning quality module will be an advantage). We Offer Competitive compensation package Modern working environment with state-of-the-art facilities and technologies Challenging assignments in a fast growing and innovative industry Position in a dynamic, international team of highly skilled professionals Various opportunities for personal and professional development within a global organization Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check. For more information on SHL Medical, please visit: shl-medical.com
